Therapeutic methods and devices following myocardial infarction

ABSTRACT

Described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber to support the affected region within 72 hours after myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority as a continuation of U.S. patentapplication Ser. No. 13/973,868, filed on Aug. 22, 2013, titled“THERAPEUTIC METHODS AND DEVICES FOLLOWING MYOCARDIAL INFARCTION,” nowU.S. Patent Application Publication No. 2013-0338695-A1, which is acontinuation of U.S. patent application Ser. No. 12/129,443, filed onMay 29, 2008, titled “THERAPEUTIC METHODS AND DEVICES FOLLOWINGMYOCARDIAL INFARCTION,” now U.S. Pat. No. 8,529,430, which is acontinuation-in-part of U.S. patent application Ser. No. 11/199,633,filed on Aug. 9, 2005, titled “METHOD FOR TREATING MYOCARDIAL RUPTURE,”now U.S. Patent Application Publication No. 2006-0229491-A1, nowabandoned, which is a continuation-in-part of U.S. application Ser. No.10/212,032, filed on Aug. 1, 2002, titled “METHOD FOR IMPROVING CARDIACFUNCTION,” now U.S. Pat. No. 7,279,007, each of which is hereinincorporated by reference in its entirety.

U.S. patent application Ser. No. 12/129,443 also claims priority to U.S.Provisional Patent Application No. 60/985,171, filed on Nov. 2, 2007,titled “ENDOCARDIAL DEVICE FOR IMPROVING CARDIAC FUNCTION,” which isherein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference

BACKGROUND

The present invention relates generally to the field of treating heartdisease, particularly preventing remodeling following myocardialinfarction.

When normal blood supply to myocardium is stopped due to occludedcoronary artery, affected heart muscle cells get severely damaged and/ordie, i.e. the myocardium (heart muscle) becomes infracted. This mayresult in permanent damage to the heart, reduced effectiveness of theheart pumping ability, and is frequently followed by enlargement of theheart and symptoms of heart failure.

An acute myocardial infarction (AMI) may lead to severe myocardialdamage resulting in myocardial rupture. Mortality rates for myocardialrupture are extremely high unless early diagnosis and surgicalintervention are provided rapidly. Cardiac rupture is a medicalemergency. The overall risk of death depends on the speed of thetreatment provided, therefore fast and relatively easy treatment optionis needed.

Myocardial regions affected by infarction may change size and shape,i.e. remodels, and in many cases non-affected myocardium remodels aswell. The infracted region expands due to the forces produced by theviable myocardium. Whether these changes become permanent and progressto involve infracted border zones and remote non-infarcted myocardiummay depend on multiple factors, including infarct size, promptness ofreperfusion, post-infarction therapy, etc. However, even following smallinfarction, many patients treated with the state-of-the-art therapiesshow some degree of regional and subsequent global ventricular shapechanges and enlargement. Early infarct expansion results fromdegradation of the extracellular collagen framework that normallyprovides myocardial cells coupling and serves to optimize and evenlydistribute force development within the ventricular walls. In theabsence of extracellular matrix, the infracted region becomes elongated,may increase in radius of curvature, and may start thinning whichinvolves the process of myocyte “slippage”. These changes may cause animmediate increase in the radius of curvature of adjacent border zonemyocardium also result in the increase in the border zone wall stress.The cumulative chronic effect of these changes is the stress elevationwithin the ventricular walls, even in the non-infarcted myocardium.Increased stress, in turn, leads to progressive ventricular dilatation,distortion of ventricular shape, mural hypertrophy and more myocardialstress increase, ultimately causing deterioration of the heart pumpfunction. FIG. 18 shows a summary flowchart illustrating the effects ofacute myocardial infarction.

Therapies for treatment of disorders resulting from cardiac remodeling(or complications of remodeling) are highly invasive, risky andexpensive, and are commonly only done in conjunction with otherprocedures (such as heart valve replacement or coronary artery by-passgraft). These procedures are usually done several months or even yearsafter the myocardial infarction when hear is already dilated andfunctioning poorly. Thus, it would be beneficial to treat myocardialinfarction prior to remodeling.

Described herein are methods and devices which may be used for theimmediate and early treatment of myocardial infarction. Cardiac rupturepost myocardial infarction needs to be treated immediately. The earlyand rapid appearance of infarct and border zone lengthening and earlyinfarct expansion may be prevented by the early treatments describedherein to prevent or attenuate initial myocardial infarct regionexpansion early after myocardial infarction. These methods and implantsmay provide an immediate mechanical effect to prevent or attenuateventricular remodeling, and may also be used in conjunction withtherapeutic agents and/or cells to the cardiac endothelium.

SUMMARY OF THE DISCLOSURE

Described herein are methods, devices and systems for treatment theheart following myocardial infarction. In general, these methodstypically require the application of a treatment device that supportsand/or isolates the infracted region of the heart within about 72 hoursof the ischemic event. These methods may be used, for example, to treata portion of the left ventricle that is affected by myocardialinfarction.

In general, a treatment device may be a support device that providesmechanical support to the region of the heart affected by the myocardialinfarction, and/or a partitioning device (e.g., including a membrane)that at least partially isolates the region of the heart chamberaffected by the myocardial infarction and/or cardiac rupture. In somevariations the treatment device is both a support device and apartitioning device.

For example, described herein is a method of preventing cardiac rupturefollowing myocardial infarction comprising delivering a device to aheart chamber exhibiting myocardial infarction within 72 hours ofmyocardial infarction (wherein the device comprises a reinforcedmembrane) and deploying the device in the chamber adjacent the region ofthe chamber wall exhibiting myocardial infarction.

The method may also include the step of identifying the region of theheart chamber exhibiting myocardial infarction. Any appropriate methodof identifying the region of the heart chamber exhibiting the myocardialinfarction may be used, including visual inspection, electricalinspection, imaging by echocardiography, magnetic resonance orcomputerized tomography, or the like. For example, electrical inspectionmay be performed by the use of ECG measurements and analysis, or the useof electrodes on or around the heart tissue. Visual inspection may bedone using direct (light) visualization, or by labeling for markers orreactivity. For example, ultrasound may be used to identify region ofthe heart affected by the myocardial infarction.

As mentioned, a treatment device may include a membrane (e.g., areinforced membrane). The membrane may be non-porous or porous to allowfluid (including blood) exchange across it. The device may include anexpandable frame. The membrane may be attached or connected to theexpandable frame. The expandable frame may be formed of an elastic orsuperelastic material, such as a shape memory material (e.g., Nitinol™,or other super-elastic materials). The expandable frame may be formed ofa plurality of struts that extend from a hub. The device may alsoinclude a foot (e.g., a non-traumatic foot) for contacting the wall ofthe chamber. In some variations the device is configured so that onlyminimal (if any) space is partitioned.

The step of delivering the device may include delivering the device in acollapsed configuration. In general, the delivery step may include thestep of delivering the device in a collapsed state through a catheter orother inserter. Thus, the device may be held in a first, collapsed ordelivery, configuration and may be deployed by expanding into thedeployed configuration. The device may be self-expanding, or it may beexpanded using a mechanical expander such as a balloon or otherstructure. Thus, the step of delivering the device may include using adelivery catheter.

When a device is used to treat the heart, the device may be sealed aboutthe periphery of the membrane of the device against the chamber wall ofthe heart being treated. Any appropriate sealing technique may be used.For example, the device may include a seal region, e.g., an expandable,inflatable, or other region. Examples of devices including a seal areprovided herein, and may also be found, for example, in US patentapplication publication No. 2006/0281965, herein incorporated byreference in its entirety.

The step of deploying the device may therefore also include isolatingthe region of the chamber wall exhibiting myocardial infarction from therest of the chamber.

The step of deploying the device may also comprise partitioning theheart chamber into a main productive portion and a secondarynon-productive portion, with the region of the chamber exhibitingmyocardial infarction or cardiac rupture forming a part of the secondarynon-productive portion.

In some variations the treatment device may include anchors orattachments for securing the device to the wall of the heart chamber.For example, the device may include hooks and/or barbs on the membraneand/or expandable frame. Thus, the methods of preventing remodeling dueto myocardial infarction may include the step of securing or anchoringthe device to the heart wall. In particular, the device may be anchoredor secured to the heart wall over the region of myocardial infarction.

One or more therapeutic agents may also be delivered to the heart tissue(e.g., the heart wall) from the device. For example, the device may becoated or impregnated with a therapeutic material. In some variations atherapeutic material is added to the heart chamber after the device isinserted, for example in the space between the device and the heartwall.

Also described herein are methods of preventing cardiac remodelingfollowing myocardial infarction comprising the step of: delivering adevice to a left ventricle within 72 hours of myocardial infarction(wherein the device comprises a reinforced membrane) and deploying thedevice in the left ventricle adjacent a region of the left ventricleexhibiting myocardial infarction.

Also described herein are methods of preventing cardiac remodelingfollowing myocardial infarction. These methods may include delivering asupport device to a heart chamber exhibiting myocardial infarctionwithin 72 hours of myocardial infarction (wherein the support devicecomprises a an expandable frame) and deploying the support device in thechamber adjacent the region of the chamber wall exhibiting myocardialinfarction. As mentioned, the method may also include the step ofidentifying the region of the heart chamber exhibiting myocardialinfarction.

The step of delivering the support device may comprise delivering thesupport device in a collapsed configuration. The support device may beany of the treatment devices described herein; for example, the supportdevices may be a device having a plurality of struts extending from acentral hub. The support device may include a reinforced membrane (whichmay be impermeable, or permeable, or semi-permeable). The support devicemay include a foot (e.g., a non-traumatic foot), or a non-traumatic hub.

The step of deploying the support device may include securing thesupport device to the wall of the chamber. In general, the treatmentdevices described herein may dynamically flex as the wall of the chambermoves. For example, the support device may be made of a material (e.g.,a shape memory alloy) that supports the wall, and flexes as the heartbeats.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic view of a patient's heart having a myocardialinfarct.

FIG. 1B is a schematic view of the patient's heart of FIG. 1A with aventricular septal defect resulting from a rupture in the heart wall.

FIG. 1C is a schematic view of the patient's heart of FIG. 1B aftertreatment following rupture of the heart wall.

FIG. 1D is a schematic view of the patient's heart after immediate earlytreatment, as described herein.

FIG. 2A is a schematic view of a patient's heart exhibiting a myocardialinfarct with free wall rupture of the left ventricular chamber.

FIG. 2B is a schematic view of the patient's heart of FIG. 2A with aleft ventricular chamber tamponade.

FIG. 2C is a schematic view of the patient's heart of FIG. 2B aftertreatment following development of tamponade.

FIG. 3 is an elevational view of a device in an expanded configuration.

FIG. 4 is a plan view of the device shown in FIG. 3 illustrating theupper surface of the device.

FIG. 5 is a bottom view of the device shown in FIG. 3.

FIG. 6 is a perspective view of a non-traumatic tip of the distallyextending stem of the device shown in FIG. 3.

FIG. 7 is a partial cross-sectional view of a hub of the device shown inFIG. 4 taken along the lines 7-7.

FIG. 8 is a transverse cross-sectional view of the hub shown in FIG. 7taken along the lines 8-8.

FIG. 9 is a longitudinal view, partially in section of a reinforcing riband membrane at the periphery of the device shown in FIG. 3.

FIG. 10 is a schematic elevational view, partially in section, of adelivery system for a device such as the device shown in FIGS. 3 and 4.

FIG. 11 is a transverse cross-sectional view of the delivery systemshown in FIG. 10 taken along the lines 11-11.

FIG. 12 is an elevational view, partially in section, of the hub shownin FIG. 7 secured to a helical coil of the delivery system shown in FIG.10.

FIGS. 13A-13E are schematic views of a patient's left ventricularchamber illustrating the deployment of the device shown in FIGS. 3 and 4with the delivery system shown in FIG. 10 to a patient's heart chamber(e.g., left ventricle).

FIG. 14 is a schematic view of the patient's heart after treatmentaccording to a method of the present invention.

FIG. 15A illustrate one variation of an implant which may be used withthe present invention.

FIG. 15B shows another variation of an implant which may be used withthe present invention.

FIG. 15C is a schematic view of a heart in which the implant of FIG. 15Ahas been implanted.

FIG. 16A illustrates another variation of an implant which may be usedwith the present invention.

FIG. 16B is a schematic view of a heart in which the implant of FIG. 16Ahas been implanted.

FIGS. 17A and 17B show another variation of an implant which may be usedfollowing acute myocardial infarction.

FIGS. 17C and 17D illustrate a delivery system for delivering an implantsuch as the implant of FIGS. 17A and 17B.

FIG. 18 schematically illustrates the effects of myocardial infarction.

FIGS. 19A and 19B is a schematic illustration of a heart in which theimplant has been applied.

DETAILED DESCRIPTION

Described herein are methods of treating a patient to prevent or correctcardiac remodeling following myocardial infarction. In general thesemethods may include inserting or implanting a device in a heart chamberwithin 72 hours after myocardial infarction, or shortly after adetermination of myocardial infarction. The device is preferably placedwithin the region of the heart chamber exhibiting one or more indicationof myocardial infarction. The device may be a support device (e.g., aresilient frame) and/or a partitioning device.

For example, FIG. 1A is a schematic illustration of a patient's heart 10showing the right ventricle 11 and the left ventricle 12 with the mitralvalve 13 and aortic valve 14. A pericardium membrane 15 is shownsurrounding the heart 10. At least a portion of myocardium layer 17 ofthe left ventricle 12, as shown in FIG. 1A, is exhibiting an area ofinfarct 18 (“MI”) extending along a portion of ventricular septum wall19 which separates the right and left ventricles. This region mayexhibit characteristics of an incipient rupture. FIG. 1B illustrates theadvancing of the infarct leading to the generation of a rupture oropening 20 in the septum wall 19, a condition referred to as VSD. Asshown in FIG. 1B oxygenated blood 21 flows directly to the rightventricle 11 through the septum opening 20. As a result of thismovement, or shunting, at least two consequences are reached, firstly,the right portion of the heart works harder pumping a greater volume ofblood than it normally would, and secondly, the amount of oxygenatedblood in the left ventricle is reduced leading to a lower oxygen levelto the other tissues of the body.

In some variations, the heart may be treated after the development ofthe rupture, as illustrated in FIG. 1C. FIG. 1C illustrates the leftventricle 12 of FIG. 1B after it has been partitioned, with the use of apartitioning device 30 according to the present invention and asdescribed further below, into a main productive or operational portion23 and a secondary, essentially non-productive portion 24. As can beseen from FIG. 1C, with fluid path to the septum opening blocked orreduced, the normal flow of blood from the left ventricle to the rest ofthe body through the aortic valve is restored.

In some variations, it may be preferable to treat the heart followingmyocardial infarction prior to remodeling such as the formation of therupture shown in FIGS. 1B and 1C. For example, FIG. 1D shows theschematic illustration of the heart of FIG. 1A shortly afterdetermination of a myocardial infarction. The region of the heartchamber exhibiting myocardial infarction (the area of infarct 18) isindicated, and in this example a device 30 has been deployed toreinforce this region. As a part of the method, the device is deployedinto the heart chamber adjacent to the region of the heart chamberexhibiting myocardial infarction shortly after a determination of themyocardial infarction has been made. Generally, this occurs prior tosubstantial remodeling of the heart. For example, this may be less than72 hours after the myocardial infarction, or less than a few days afterthe determination of a myocardial infarction.

The occurrence of a myocardial infarction may be determined by anyappropriate method, including diagnostics based on physical examination,electrocardiogram, blood (or other tests) for cardiac markers,angiograms, or the like. For example, enzyme markers (e.g., SGOT, LDH,creatine kinase), or other markers (e.g., troponins, glycogenphoshyorylase isoenzyme, myoglobin, etc.) may help determine myocardialinfarction. The region of the heart affected by the myocardialinfarction may also be determined. For example, visualization techniques(direct or indirect) may be used. For example, angiograms may be used.Other visualization techniques, including scanning (e.g.,echocardiography, CT scanning, etc.), electrical mapping, etc. may alsobe used to localize an area of infarct.

FIG. 2A is a schematic illustration of a patient's heart 10 showing theright ventricle 11 and the left ventricle 12 with the mitral valve 13and aortic valve 14. The pericardium membrane 15 is shown surroundingthe heart. A pericardium (pericardial complex) consists of an outerfibrous layer and an inner serous layer. The pericardial space 16normally contains 20-50 mL of fluid. At least a portion of themyocardium layer 17 of the left ventricle 12, as shown in FIG. 2A, isexhibiting an area of infarct 18 (“MI”) extending along a portion of theleft ventricle 12, which may result in a wall rupture or opening leadingto a movement of blood 21 from the left ventricle into the pericardialspace 16, as illustrated in FIG. 2B.

FIG. 2B shows the remodeling of the heart following MI. In FIG. 2A thedamage from the infarct has advanced, leading to the rupture or opening20 which is increasing in size. As shown in FIG. 2B, the flow of theblood 21 into the pericardial space 16 increases over time leading to agreater accumulation of blood in the pericardial space. This movementand accumulation of blood in the pericardial space, a condition referredto as ventricular tamponade, results in reduced ventricular filling andsubsequent hemodynamic compromise.

This damage may be prevented or reversed by implanting or inserting asupport and/or partitioning device, as shown in FIG. 2C. FIG. 2Cillustrates the left ventricle 12 of FIG. 2A after a device 30 has beeninserted. This device 30 is a partitioning device which both supportsthe damaged area, and may partition it from other portions of the heartchamber, into the main productive or operational portion 23 and thesecondary, essentially non-productive portion 24. As can be seen from 1Dand 2C, supporting the damaged region of the heart chamber (e.g., thearea of infarct 18), and in some variations partitioning it, may preventor reverse the remodeling of the heart and help restore the normal flowof blood from the left ventricle to the rest of the body through theaortic valve.

In general, a device for preventing remodeling of the heart comprises aflexible support frame and one or more anchors, and may optionallyinclude one or more of a foot region (e.g., an atraumatic foot region)and a membrane. These treatment device may be referred to as supportdevices or partitioning devices.

FIGS. 3-6 illustrate one example of a device 30 (in this variation apartitioning device) which embodies features of the invention and whichmay be utilized in practicing the method of the present invention. Thedevice 30 includes a partitioning membrane 31, a hub 32, preferablycentrally located on the partitioning device, and a radially expandablereinforcing frame 33 formed of a plurality of ribs 34. Preferably, atleast part of the partitioning membrane 31 is secured to a proximal orpressure receiving side 35 of the frame 33 as shown in FIG. 3. The ribs34 have distal ends 36 which are secured to the hub 32, and freeproximal ends 37 which are configured to curve or flare away from acenter line axis 38 at least upon expansion of the partitioning device.Radial expansion of the free proximal ends 37 unfurls the membrane 31secured to the frame 33 so that the membrane presents the pressurereceiving surface 35 which defines in part the productive portion 23 ofthe patient's partitioned heart chamber. A peripheral edge 39 of themembrane 31 may be serrated as shown.

A continuous expansive strand 40 extends around the periphery of themembrane 31 on the pressure receiving side 35 thereof to apply pressureto the pressure side of the flexible material of the membrane toeffectively seal the periphery of the membrane against the wall of theventricular chamber. Ends 41 and 42 of the expansive strand 40 are shownextending away from the device in FIGS. 3 and 5. The ends 41 and 42 maybe left unattached or may be secured together, e.g. by a suitableadhesive, to the membrane 31 itself. While not shown in detail, themembrane 31 has a proximal layer secured to the proximal faces of theribs 34 and a distal layer secured to the distal faces of the ribs in amanner described in co-pending application Ser. No. 10/913,608, filed onAug. 5, 2004, assigned to the assignee of the present invention, andincorporated herein by reference in its entirety.

The hub 32 shown in FIGS. 6 and 7 preferably has a distally extendingstem 43 with a non-traumatic support component 44. The support component44 has a plurality of pods or feet 45 extending radially away from thecenter line axis 38 and the ends of the feet 45 are secured to struts 46which extend between adjacent feet. A plane of material (not shown) mayextend between adjacent feet 45 in a web-like fashion to provide furthersupport in addition to or in lieu of the struts 46.

As shown in FIG. 7, the distal ends 36 of the ribs 34 are secured withinthe hub 32 and, as shown in FIG. 8, a transversely disposed connectorbar 47 is secured within the hub which is configured to secure the hub32 and thus the device 30 to a delivery system such as that shown inFIGS. 10-12.

FIG. 9 illustrates the curved free proximal ends 37 of ribs 34 which areprovided with sharp tip elements 48 configured to engage, and preferablypenetrate into, the wall of the heart chamber and hold the device 30 ina deployed position within the patient's heart chamber so as topartition the ventricular chamber into a productive portion and anon-productive portion. These sharp tip elements may also be referred toas anchors.

The connector bar 47 of the hub 32, as will be described later, allowsthe device 30 to be connected to the non-traumatic component 44 whichcan be secured to a delivery catheter for delivery and to be releasedfrom the delivery system within the patient's heart chamber. The distalends 36 of the reinforcing ribs 34 are secured within the hub 32 in asuitable manner or they may be secured to the surface defining the innerlumen of the hub or they may be disposed within channels or bores in thewall of the hub 32. The distal end 36 of the ribs 34 are pre-shaped sothat when the ribs are not constrained, other than by the membrane 31secured thereto (as shown in FIGS. 3 and 4), the free proximal ends 37thereof expand to a desired angular displacement, away from thecenterline axis 38, of about 20° (degree) to about 90°, preferably about50° to about 80°. The unconstrained diameter of the device 30 ispreferably greater than the diameter of the heart chamber at thedeployed location of the device so that an outward force is applied tothe wall of the heart chamber by the at least partially expanded ribs 34during systole and diastole so that the resilient frame 33 augments theheart wall movement.

FIGS. 10-12 illustrate one suitable delivery system 50 delivering adevice 30 (e.g., the device shown in FIGS. 3 and 4) into a patient'sheart chamber to prevent remodeling of the heart chamber, as illustratedin FIGS. 13A-13E. The delivery system 50 includes a guide catheter 51and a delivery catheter 52. The present invention may be practiced afterthe myocardial infarct (e.g., within 72 hours, within 48 hours, etc.),but before remodeling has lead to the creation of rupture or openings(such as 20) in the heart chamber. In some variations, the methodsdescribed herein may be used after 72 hours from the myocardialinfarction (e.g., within 96 hours, within 120 hours, within 168 hours,within 2 weeks, within 1 month), to minimize the size and/or the effectsof remodeling.

The guide catheter 51 has an inner lumen 53 extending between proximaland distal ends, 54 and 55. A flush port 57 on the proximal end 54 ofguide catheter 51 is in fluid communication with the inner lumen 53 forinjecting therapeutic or diagnostic fluids thereto.

The delivery catheter 52 has an outer shaft 58 with an interior 59, andan adapter 60 at a proximal end thereof with a proximal injection port61 which is fluid communication with interior 59 for injectingtherapeutic or diagnostic fluids thereto. A hemostatic valve (not shown)may be provided at the proximal end 54 of the guide catheter 51 to sealabout the outer shaft 58 of the delivery catheter 52.

As shown in more detail in FIG. 11, the outer shaft 58 has an innershaft 62 with an interior 63, and is disposed within the interior 59 ofthe outer shaft and is secured to an inner surface 64 of the outer shaft58 by webs 65 which extend along a substantial length of the inner shaft62. The webs 65 define in part passageways 66 formed between the innerand outer shafts 62 and 58. The injection port 61 is in fluidcommunication with passageways 66 for directing therapeutic and/ordiagnostic fluids thereto.

A torque shaft 67, preferably formed from hypotubing (e.g., stainlesssteel or superelastic NiTi) and having an inner lumen 68, is rotatablydisposed within an inner lumen 69 of the inner shaft 62, and is securedat a proximal end 70 thereof within an adapter 71 with a rotating knob72.

A balloon inflation port 73, preferably proximal to the rotating knob72, is in fluid communication with the inner lumen 68 of the torqueshaft 67.

A helical coil screw 74 is secured to a distal end 75 of the torqueshaft 67 and rotation of the torque knob 72 on the proximal end 70 ofthe torque shaft 67 rotates the screw 74 on the distal end 75 of torqueshaft 67 to facilitate deployment of the device 30. An inflatableballoon 76 at its proximal end 77 is sealingly secured (e.g., by way ofadhesive 78) about the torque shaft 67 proximal to the distal end 75 ofthe torque shaft and has an interior 79 in fluid communication with theinner lumen 68 of the torque shaft 67. Inflation fluid may be deliveredto the interior 79 of the balloon through port 73. Inflation of theballoon 76 by inflation fluid through port 73 facilitates securing thedevice 30 to the heart wall.

Prior to performing the procedure shown in FIGS. 13A through 13E, thepatient may be identified as having recently (e.g., within 72 hours) hada myocardial infarction, by any appropriate method. The region of theheart effected (e.g., the region of the heart chamber effected) may beidentified as well. In FIGS. 13A through 13E, the device 30 (apartitioning device in this example) is delivered through the deliverysystem 50 which includes the guide catheter 51 and the delivery catheter52. The support or partitioning device 30 is collapsed to a firstdelivery configuration which has small enough transverse dimensions tobe slidably advanced through the inner lumen 53 of the guide catheter51. Preferably, the guide catheter 51 has been previously percutaneouslyintroduced and advanced through the patent's vasculature, such as thefemoral artery, in a conventional manner to the desired heart chamber,such as the left ventricle 12. The delivery catheter 52 with the device30 attached is advanced through the inner lumen 53 of the guide catheter51 until the device 30 is ready for deployment from the distal end ofthe guide catheter 51 into the patient's heart chamber, such as leftventricle 12, to be treated.

The device 30 mounted on the screw 74 is urged partially out of theinner lumen 53 of the guide catheter 51 until the support component 44of the hub 32 engages the heart wall as shown in FIG. 13B with the freeproximal ends 37 of the ribs 34 in a contracted configuration within theguide catheter. The guiding catheter 51 is withdrawn while the deliverycatheter 52 is held in place until the proximal ends 37 of the ribs 34exit a distal end 55 of the guiding catheter 51. The free proximal ends37 of ribs 34 expand outwardly to press the sharp proximal tips 48 ofthe ribs 34 against and preferably into the tissue lining the heartchamber.

With the device deployed within the heart chamber and preferablypartially secured therein, inflation fluid is introduced through theinflation port 73 into the inner lumen 68 of the torque shaft 67 andinto the balloon interior 79 to inflate the balloon 76. The inflatedballoon 76 presses against the pressure receiving surface 35 of themembrane 31 of the device 30 to ensure that the sharp proximal tips 48are pressed well into the tissue lining the heart chamber. In variationsof the device that do not include a membrane, the balloon may expand theframe by pressing against the ribs 34.

With the device 30 properly positioned within the heart chamber, theknob 72 on the torque shaft 67 is rotated (e.g., counter-clockwise) todisengage the helical coil screw 74 of the delivery catheter 52 from thestem 43 of the non-traumatic support component. The counter-clockwiserotation of the torque shaft 67 rotates the helical coil screw 74 whichrides in the stem 43 of non-traumatic support component secured withinthe hub 32. Once the helical coil screw 74 disengages, the stem 43, thedelivery system 50, including the guide catheter 51 and the deliverycatheter 52, may then be removed from the patient.

In this example, the device 30 partitions the patient's heart chamber,such as left ventricle 12, into the main productive or operationalportion 23 and the secondary, essentially non-productive portion 24. Theoperational portion 23 is much smaller than the original ventricularchamber and provides for an improved ejection fraction. The device mayalso support the wall of the heart chamber. The partitioning mayincrease the ejection fraction and provides an improvement in bloodflow. Over time, the non-productive portion 24 may fill first withthrombus and subsequently with cellular growth. Bio-resorbable fillerssuch as polylactic acid, polyglycolic acid, polycaprolactone andcopolymers and blends thereof may be employed to initially fill thenon-productive portion 24. Fillers may be suitably supplied in asuitable solvent such as dimethylsulfoxide (DMSO). Other materials whichaccelerate tissue growth or thrombus may be deployed in thenon-productive portion 24 as well as non-reactive fillers. It should benoted that although the present figures describe the treatment of theleft ventricle, the same can be applied to other chambers of the heart.

FIG. 14 illustrates an alternative design which embodies features of adevice usable in practicing methods having features of the presentinvention, in which the device 30′ is provided with an eccentric-shapedmembrane 31′ which is well suited for treating VSD lesions that mayoccur further up (more proximal) the ventricular septum because of thedifferent anatomical features and physiologic action of the ventricularseptum versus the anterior free wall. The septal wall primarily moves inand out only, relative to the chamber, versus the free wall that has arotation component to its excursion. Secondly, the outflow track whichcomprises the upper half of the ventricular septal wall below the aorticvalve has very little or no trebeculation. It is particularly wellsuited for placement of the device placed to address necrotic failure ofthe tissue of the ventricular septum. In the embodiment shown in FIG.14, the device is shown with a nubbin foot 45′ (and not the extendedstem foot) allowing the device to sit more distally and intimately withthe apex.

The details of the device 30′ shown in FIG. 14 are essentially the sameas in the previous embodiments and elements in this alternativeembodiment are given the same reference numbers but primed as similarelements in the previously discussed embodiments. The device 30′ forms aconical shape as in the previously discussed embodiments but theperipheral base of the conical shape which engages the wall that has afirst dimension in a first direction greater than a second dimension ina second direction. Preferably, the second direction is at a right anglewith respect to the first direction. The lengths of the ribs 34′ areadjusted to provide the desired shape to the periphery of the devicewhich engages the interior of the heart chamber.

Any of the devices described herein (e.g., the devices 30 31′) may beconveniently formed by the method described in co-pending applicationSer. No. 10/913,608, which is incorporated herein by reference in itsentirety.

In variations having a membrane, porous ePTFE materials may bepreferred. Alternatively, the membrane 31 may be formed of suitablebiocompatible polymeric material which includes Nylon, PET (polyethyleneterephthalate) and polyesters such as Hytrel. The membrane 31 ispreferably foraminous in nature to facilitate tissue ingrowth afterdeployment within the patient's heart. The delivery catheter 52 and theguiding catheter 51 may be formed of suitable high strength polymericmaterial such as PEEK (polyetheretherketone), polycarbonate, PET, Nylon,and the like. Braided composite shafts may also be employed.

FIGS. 15A through 16B illustrate other variations of devices and methodsfor using them to prevent remodeling. FIG. 15A sows a device that doesnot include an occlusive membrane. In this variation of a supportdevice, a plurality of struts 1501 extend from a central hub 1503. Theends of each strut 1501 terminate in an anchor 1505. The struts aretypically flexible, and may be collapsed into a delivery configurationand expanded (e.g., self-expanded) into a deployed configuration. Thesupport device shown in FIG. 15B is similar, but has struts of differentlengths, similar to the device shown in FIG. 14. FIGS. 15C shows aschematic illustration of a heart in which the support device of FIG.15A has been implanted adjacent a region of the chamber wall exhibitingmyocardial infarction. In some variations, the devices may be anchoredalong the length of the struts rather than, or instead of, just at theends. In some variations the hub is anchored to the heart chamber wall.

FIG. 16A shows another variation of an implant, similar to the implantshown in FIG. 3, without the plurality of pods or foot 45. In thisexample, the hub 1603 may directly contact the wall of the heartchamber. FIG. 16B shows the device of FIG. 16A in the heart.

As mentioned, the implant devices used to treat post-acute myocardialinfracted hearts may be configured so that the support framework (e.g.,struts) and/or any membrane may be positioned adjacent, contacting, orvery close to the wall of the heart. For example, FIGS. 19A and 19B showcross-sectional views of two hears that have devices 1901, 1901′implanted adjacent to the wall in the region affected by the acutemyocardial infarction 1903, 1903′.

FIGS. 17A and 17B illustrate another variation of a device that may beimplanted following acute myocardial infarction in order to preventcardiac remodeling or damage (configured as an endocardial implant). Inthis example, the device is configured to be anchored immediatelyadjacent to the heart wall (e.g., ventricle wall) across from the regionof the infarct. The implant includes a frame comprising a plurality ofexpandable struts which extend from a central hub. The base of the hubin this example includes an anchor (“active anchor”) which may beinserted into the heart wall. For example, the hub anchor may be screwedinto the heart wall by rotating the device to at least partiallypenetrate the heart wall and secure the device in place. In addition,the device may also include one or more passive anchors on the struts ofthe frame, as illustrated. In this variation the struts are at leastpartially covered by a membrane. The implant sown in FIG. 17A is shownin side cross-section in FIG. 17B.

FIG. 17C illustrates one variation of a delivery device for deliveringthe implant to the heart so that it can be deployed and inserted. Forexample, the delivery device shown in FIG. 17C includes a deliverycatheter having an implant (shown in the collapsed state) at the distalend. FIG. 17D shows the delivery device inserting the implant into theleft ventricle of a heart.

To the extent not otherwise described herein, the various components ofthe devices and delivery systems may be formed of conventional materialsand in a conventional manner as will be appreciated by those skilled inthe art.

Cardiac endothelium plays an important role in control of theinflammatory response of the myocardium, growth of the heart musclecells, contractile performance and rhytmicity of the cardiomyocytes.Cardiac endothelial dysfunction has also important role in thepathogenesis of cardiac failure. Therefore, it may be advantageous toselectively deliver therapeutic agents and/or cells to the endotheliumin controlled and predictable fashion. The devices (e.g., support deviceand partitioning devices) described herein may be used to treatdisorders by delivering a therapeutic material, including drugs andcells. For example, a frame of a device and/or the membrane of a devicecan be coated and/or impregnated with a biodegradable coating containingtherapeutic agents and deliver these agents to the endothelium.Similarly, a delivery catheter can provide access to infuse varioussolutions of the therapeutic agents or cells to the area between thedevices (e.g., a membrane of the device) and the endothelium, providingprecise control of the delivery process to facilitate healing and localregeneration. Any appropriate therapeutic agents may be used, includingcytokines, chemokines, inflammatory mediators, growth factors, inotropicagents, anti-arrhythmic agents, other pharmaceutical agents commonlyused for treatment post-infarction condition, and various types of cells(myocytes, myoblasts, stem cells).

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made. Moreover, individual features of embodimentsof the invention may be shown in some drawings and not in others, butthose skilled in the art will recognize that individual features of oneembodiment of the invention can be combined with any or all the featuresof another embodiment. Accordingly, it is not intended that theinvention be limited to the specific embodiments illustrated. It isintended that this invention to be defined by the scope of the appendedclaims as broadly as the prior art will permit.

Terms such as “element,” “member,” “component,” “device,” “section,”“portion,” “step,” “means,” and words of similar import, when usedherein shall not be construed as invoking the provisions of 35 U.S.C.§112(6) unless the following claims expressly use the term “means”followed by a particular function without specific structure or the term“step” followed by a particular function without specific action.Accordingly, it is not intended that the invention be limited, except asby the appended claims.

What is claimed is:
 1. An implant for treating a diseased condition of aheart, the implant comprising: a flexible support frame comprising aplurality of radially expandable struts having a collapsed configurationand an expanded deployed configuration; a membrane supported by theflexible support frame; and a low profile hub configured to place theplurality of struts adjacent to the heart wall when the plurality ofstruts are in the expanded deployed configuration, wherein the pluralityof struts extend from the low profile hub such that each strut has abase portion proximate the hub and an tip portion associated with a freeend of the strut.
 2. The implant of claim 1, wherein the base portionsof the plurality of struts proximate the hub are curved inwards withrespect to a center line axis extending through the hub in the expandeddeployed configuration.
 3. The implant of claim 2, wherein the baseportions of the plurality of struts are configured to be biased againstthe ventricle wall in the expanded deployed configuration.
 4. Theimplant of claim 1, wherein the tip portions of the plurality of strutsare curved outwards with respect to a center line axis extending throughthe hub.
 5. The implant of claim 1, wherein the base portions of theplurality of struts proximate the hub are curved inwards and the tipportions of the plurality of struts are curved outwards with respect toa center line axis extending through the hub.
 6. The implant of claim 1,wherein the plurality of struts are tipped with anchors that areconfigured to secure the implant to the heart.
 7. The implant of claim1, wherein the membrane is occlusive.
 8. The implant of claim 1, whereinthe low profile hub is non-traumatic.
 9. An implant for treating adiseased condition of a heart, the implant comprising: a flexiblesupport frame comprising a plurality of expandable struts having acollapsed configuration and an expanded deployed configuration, whereinthe plurality of struts are configured to be biased against an interiorsurface of a ventricle wall in the expanded deployed configuration; anda membrane supported by the flexible support frame.
 10. The implant ofclaim 9, wherein the expandable struts are tipped with anchorsconfigured to secure the support frame to the interior surface of theventricle wall.
 11. The implant of claim 9, further comprising a hub,wherein the expandable struts extend radially from the hub.
 12. Theimplant of claim 11, wherein the hub has a low profile configured toplace the plurality of struts adjacent to the heart wall when theplurality of struts are in the expanded deployed configuration withinthe ventricle.
 13. A method for treating a diseased condition of aheart, the method comprising: inserting an implant in a collapsedconfiguration into a ventricle of the heart, the implant comprising aflexible support frame comprising a plurality of radially expandablestruts, and a membrane supported by the flexible support frame; andexpanding the support frame until the plurality of radially expandablestruts and the membrane are positioned adjacent the ventricle wall. 14.The method of claim 13, wherein the implant is inserted percutaneouslyinto the ventricle.
 15. The method of claim 13, further comprisinganchoring the struts into the ventricle wall.
 16. The method of claim13, wherein the implant further comprises a low profile hub configuredto place the plurality of struts adjacent to the ventricle wall when theplurality of struts are expanded, wherein the plurality of struts extendfrom the low profile hub.
 17. The method of claim 16, further comprisingpositioning the low profile hub at the apex of the ventricle.
 18. Themethod of claim 13, further comprising covering a diseased portion ofthe ventricle wall with the support frame and membrane.
 19. The methodof claim 13, further comprising reducing remodeling of a diseasedportion of the ventricle wall.
 20. The method of claim 13, wherein thestruts are configured to be biased against the ventricle wall after thesupport frame is expanded.